Halogen Moisture Analysis in Process For Effective Tablet Production

A pharmaceutical company with a global footprint produces a diverse range of medications at its US site. Targeting bacterial, viral and parasitic infectious diseases as well as conditions such as cardiovascular and neurological disorders, the active ingredients are synthesized and formulated in a busy, round-the-clock operation.

To comply with GLP, GMP and FDA regulations, and to ensure the quality and consistency of its finished products, the company undertakes the rigorous evaluation of reagents, intermediates, APIs and excipients. 

An important aspect of this regimen is moisture analysis, which is employed in process. The moisture content of the materials included in each tablet must not exceed 3–5% for successful pressing. Excess moisture may clog the press, while too little may impede compaction— making accurate, precise measurements essential to shelf life and efficacy.

A versatile solution

For years, the company has relied on METTLER TOLEDO halogen moisture analyzers to produce reliable data within minutes, and recently upgraded to the newest models to capitalize on their powerful features.

The company opted for HX204 halogen moisture analyzers, which offer readability down to 0.001%. Results are typically ready in less than 10 minutes, and with the new QuickPredict™ function can reliably be anticipated in even less time. Custom methods for each sample type can be designed with the assistance of the Method Wizard, and saved as shortcuts on the home screen for launch with OneClick™. In addition, user management and method assignment features ensure that only authorized operators can undertake analyses, while built-in control limits easily show, at the point of use, whether samples have passed or failed assessment.

Tailored assistance

METTLER TOLEDO application specialists assisted with setup of the new instruments and development of two dedicated methods. QC personnel were delighted by the units’ simple and intuitive interface and

the method shortcuts. The eyelevel ErgoStand™, which reduces neck strain, was also a hit on the busy production floor, as were the hanging weighing pan and stainless steel interior, which permit easy cleaning between samples or in case of spills. The company arranged for twice yearly service to ensure that results remain in spec; between visits, the SmartCal™ routine testing substance easily enables operators to check instrument performance.

Importantly, the HX204 can store past results, together with details of the method used; results can also be exported to a server or transferred to a printer, further supporting compliance and adherence to the ALCOA+ framework. The new instruments’ streamlined design and smooth operation have facilitated the company’s transition from the older models. With the benefit of their fast, accurate results, QC personnel remain confident in the quality of their formulations, and the sophisticated compliance features guarantee audit-readiness – providing the quality of medication on which the company’s millions of customers depend.